The CUSA® Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Neurosurgery. Plastic and Reconstructive surgery. Orthopedic Surgery. Gynecological Surgery and Thoracic Surgery and the following specific uses:

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Device Description

The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device to be added to the Integra Lifesciences Corporation family of tissue ablation products. There are two (2) systems currently marketed in the United States: CUSA® Excel+ Ultrasonic Surgical Aspirator System and CUSA® NXT Ultrasonic Tissue Ablation System These two systems as well as all predecessor devices share(d) the same principle of operation. All CUSA systems are surgical aspirators which use ultrasonics and cavitation to fragment and emulsify tissue, and aspiration at the end of the surgical tip to remove unwanted tissue. Each model has unique features and attributes that may not be found in the others. Like the predicate devices. CUSA Clarity is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies, and removes unwanted tissue. It allows for the selective of target tissue while preserving vessels, ducts, and other delicate structures. The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, a surgical handpiece that provides ultrasonic mechanical energy, a footswitch to allow user control over the ultrasonics, a titanium surgical tip, irrigation flue, and a suction/irrigation system (manifold tubing and vacuum canister). The CUSA Clarity system, including all accessories and components, will be labeled MR Unsafe.

AI/ML Overview

This document refers to the CUSA Clarity Ultrasonic Surgical Aspirator System, which is an ultrasonic surgical aspirator. This type of device fragments, emulsifies, and aspirates soft tissue during surgical procedures. The document does not describe the specific acceptance criteria or a detailed study proving the device meets those criteria in the way one would expect for an AI/ML powered device, image analysis software, or a diagnostic tool.

Instead, the provided text outlines the regulatory submission for a traditional medical device (an ultrasonic surgical aspirator). The focus is on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific clinical efficacy metrics for a new diagnostic or predictive algorithm.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in this type of submission for a physical surgical device.

Based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document states: "A suite of performance tests was executed to show substantial equivalence with the predicate devices." It then lists categories of testing. However, it does not provide a table with specific quantitative acceptance criteria (e.g., in terms of fragmentation rate, aspiration efficiency, or tissue selectivity) and corresponding performance metrics for the CUSA Clarity. Instead, the general "acceptance criterion" is successful completion of tests demonstrating substantial equivalence.

Acceptance Criteria Category (Inferrred)	Reported Device Performance (Summary)
Sterilization	Met per FDA Guidance documents and recognized standards
Cleaning	Met per FDA Guidance documents and recognized standards
Shipping Stability	Met per FDA Guidance documents and recognized standards
Biocompatibility	Met per FDA Guidance documents and recognized standards
Software	Met per FDA Guidance document and recognized standards
EMC and Electrical Safety	Met per FDA recognized standards
Bench Testing (Performance)	Met per various internal protocols; all design inputs fulfilled
Overall Goal	Substantial equivalence to predicate devices (CUSA Excel+ and CUSA NXT)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size used for the test set: Not explicitly stated. The document refers to "a suite of performance tests" and "50 protocols" completed successfully. These protocols would involve testing samples of the device and its components, but the specific number of units or test runs for each protocol is not provided.
Data provenance: Not explicitly stated. The testing appears to be internal to the manufacturer (Integra LifeSciences Corporation) and conducted in a lab/bench setting to verify engineering performance and compliance with standards, rather than clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not applicable in the context of this device submission. Ground truth, in the AI/ML sense, is usually associated with labeling or interpreting medical images or data. For a surgical aspirator, "ground truth" would relate to the physical performance characteristics of the device (e.g., its power output, aspiration flow, material compatibility), which are measured by instruments and verified against engineering specifications and standards, not by human experts interpreting clinical data for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for establishing consensus on "ground truth" labels in clinical data for AI/ML models. For a physical device's performance testing, results are typically determined by measurement instruments and engineering analysis against predefined specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic or prognostic tools, often involving human readers (e.g., radiologists) and sometimes comparing their performance with and without AI assistance. The CUSA Clarity is a surgical instrument, not a diagnostic imaging or AI-powered interpretation tool. No such study is mentioned or relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The CUSA Clarity is a human-operated surgical instrument. There is no "algorithm only" performance to evaluate in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As discussed, the concept of "ground truth" in the AI/ML sense is not directly applicable. The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., for sterilization, biocompatibility, electrical safety, EMC), and internal protocols that define acceptable performance ranges for physical characteristics. Compliance with these specifications and standards constitutes meeting the "ground truth" for a physical device.

8. The sample size for the training set

Not applicable. The CUSA Clarity is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Integra LifeSciences Corporation Mr. Resham Ramsay Quality, Clinical, and Regulatory Associate 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K161882

Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulation Name: Instrument, Ultrasonic Surgical Regulatory Class: Unclassified Product Code: LFL, LBK Dated: September 13, 2016 Received: September 14, 2016

Dear Mr. Resham Ramsay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161882

Device Name

CUSA Clarity Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

The CUSA® Clarity Ultrasonic System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Neurosurgery. Plastic and Reconstructive surgery. Orthopedic Surgery. Gynecological Surgery and Thoracic Surgery and the following specific uses:

General Surgery - including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

807.92(a)(1) – Submitter information
Name	Integra LifeSciences Corporation
Address	311 Enterprise Drive Plainsboro, NJ 08536 USA
Phone Number	609-275-0500
Fax Number	609-275-9445
Establishment Registration Number	9004007
Name of Contact Person	Resham Ramsay
Date Prepared	July 8, 2016
807.92(a)(2) – Name of device
Trade or Propriety Name	CUSA® Clarity Ultrasonic Surgical Aspirator System
Common or Usual Name	Ultrasonic Surgical Aspirator
Classification Name	Instrument, Ultrasonic Surgical
Classification Panel	General and Plastic Surgery
Regulation	Unclassified
Product Code(s)	LFL, LBK
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
	CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668CUSA® NXT Ultrasonic Tissue Ablation System K081459

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807.92(a)(4) - Device description

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807.92(a)(5) – Intended use of the device
The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicatedfor use in surgical procedures where fragmentation, emulsification andaspiration of soft tissue is desirable.
The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery,Gynecological Surgery and Thoracic Surgery and the following specificuses:
Indications forUse	Gastrointestinal and Affiliated Organ Surgery – including removal ofbenign or malignant tumors or other unwanted tissue, including hepaticparenchyma, in open or laparoscopic procedures, hepatic resection,tumor resection, lobectomy or trisegmentectomy, or removal of tissueduring liver allotransplantation and donor hepatectomy
	Urological surgery- including removal of renal parenchyma duringnephrectomy or partial nephrectomy
	General Surgery – including removal of benign or malignant tumors orother unwanted soft tissue in open or minimally invasive generalsurgical procedures
	Laparoscopic Surgery - including removal of hepatic parenchyma inlaparoscopic hepatic resection, lobectomy or trisegmentectomy, inlaparoscopic donor hepatectomy or laparoscopic cholecystectomy orlaparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopicappendectomy, laparoscopic colon resection or laparoscopic partialgastrectomy


807.92(a)(6) Summary of the technological characteristics of the device compared to thepredicate

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The CUSA Clarity has the same technological characteristics compared to the predicate devices. The main purpose of the CUSA Clarity at this time is to update the CUSA platform while maintaining the same underlying technology and intended use of previous CUSA devices, consolidate some of the best features from the two predicate devices into one system, and to add minor design improvements that generally focus on improving ease-of-use. Thus, the majority of the features and technology of the CUSA Clarity are not new for a CUSA device and benefit longstanding safety and/or efficacy.

807.92(b)(1-2) – Nonclinical and clinical tests submitted

A suite of performance tests was executed to show substantial equivalence with the predicate devices. Testing included, but was not limited to:

Sterilization, cleaning, shipping and stability testing per FDA Guidance documents and recognized standards
Biocompatibility testing per FDA Guidance documents and recognized standards
Software testing per FDA Guidance document and recognized standards
EMC and Electrical Safety testing per FDA recognized standards
Bench testing per various internal protocols

Testing was determined successful for all 50 protocols and supports the conclusion that all design inputs have been met. Integra LifeSciences therefore believes verification testing results for the CUSA Clarity support a determination of substantial equivalence when compared with the predicate devices.

807.92(b)(3) – Conclusions drawn from non-clinical and clinical data

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The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology, and performance of the CUSA Clarity are substantially equivalent to the predicate devices.

Regulation Number and Section

N/A